Class 2 Device Recall Siemens Rapidpoint 405 Test System

• Date Initiated by Firm: October 30, 2009
• Date Posted: March 08, 2010
• Recall Status: Terminated on September 04, 2015
• Recall Number: Z-1020-2010
• Recall Event ID: 53541
• 510(K)Number: K002738
• Product Classification: electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: RapidPoint 405 System Analyzers The RP405 is capable of testing all of the analytes listed below including Co-Oximetry. The Siemens 400 series system is intended for point of care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.
• Code Information: Software Versions prior to 3.5.1
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics Inc; 2 Edgewater Dr; Norwood MA 02062-4637
• For Additional Information Contact: 508-359-3877
• Manufacturer Reason for Recall: Software: Reference sensor failure may result in inaccurate pH reuslts
• FDA Determined Cause: Component design/selection
• Action: An "Urgent Field Safety Notice" dated September 2009 was sent via overnight mail to customers and included software Version 3.5.2 with instructions for install that will detect and prevent the reporting of potentially errant test results. The customers are requested to please install the included software update immediately and return the attached Fax back form. Siemens will provide the mandatory update to all customers with the Rapidpoint 400 /405 test system. If you have any questions, please contact your local Technical Support at 508-359-3877.
• Quantity in Commerce: 4095 units
• Distribution: Worldwide distribution: USA and Australia, Austria, Bahamas, Barbados, Belgium, Bosnia Herzeg, Brazil, Canada, Canary Islands, Chile, Croatia, Czech Republic, Egypt, France, Germany, Holy See (Vatican City State) Hong Kong, Ireland, Italy, Japan, Macedonia, Malaysia, M¿xico, New Zealand Not assigned P.R. China, Poland, Portugal, Puerto Rico, Refurb.Systems U.S.A Republic Korea, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, U.A.E., United Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CHL